For 2016, it's been all about TAF - sweet, sweet tenofovir alafenamide fumarate. What's so special about TAF, you ask? TAF (you may know it as Vemlidy) is replacing TDF (Viread) in a variety of HIV treatments because it's safer and less costly to produce. How much less? Here's a quote from the Q3'16 conference call:
John F. Milligan
We're particularly excited about the role that TAF will play. With a small daily dose and improved side effect profile, it is ideal for resource-constrained areas of the world and requires only one-tenth of the manufacturing capacity to supply the same number of patients.
TAF's manufacturing efficiency bodes well for the future profit margins in the HIV business. Now how about safety? TAF is both safer for renal health and bone density. This abstract from CROI illustrates the point clearly. 0 out of 866 patients developed clinically significant renal issues on TAF, whereas 12 out of 867 patients developed renal issues on TDF. This is statistically significant, and the efficacy results are similar. All you need to know is TAF is a safer version of TDF, and that safety is paramount in HIV treatment.
In the HCV market, side effects are important. However, they are even more crucial in HIV because the disease is chronic. In other words, treatment durations are decades rather than a few weeks. Drug-drug interactions, side effects, PK and PD data, and various other factors play a huge role in these lifetime treatment fields. TAF solved long-term concerns related to renal and bone damage seen with TDF treatments, leading to fast uptake.
When Gilead released TAF, it was quickly adopted as a preferred treatment in the US Department of Health & Human Services (DHHS) and International Antiviral Society (IAS) guidelines. It has also been adopted in the guidelines of a variety of other countries such as Germany, the UK, Spain, and Italy. In addition, guidelines are starting to label TDF-backed regimens as alternative treatments. A quote from the Wells Fargo broker conference back in September 2016 illustrates the importance of this:
